18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

Daiichi Sankyo207 enrolled

Overview

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

207

Conditions

Type 2 Diabetes Hypertension

Interventions

AmlodipineDRUG

Amlodipine 5 mg tablets , Daily for 3 weeks;

amlodipine / olmesartan medoxomil combinationDRUG

amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg

HydrochlorothiazideDRUG

hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females aged 18 to 80 years. * Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide); Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below: * Fasting plasma glucose \>=126 mg/dL (7.0 mmol/L); or * Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose \>=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or * Two-hour plasma glucose \>=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; * Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP \>130 mmHg and/or DBP \>80 mmHg) on current antihypertensive monotherapy or combination therapy. * Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria. * Females should not be pregnant or lactating and, if applicable, using adequate contraception. Exclusion Criteria: * Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator). * Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) \>=9.0% at screening; * Subjects with type 1 or type 2 diabetes mellitus requiring insulin. * Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.

Locations (21)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Sylmar, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment

Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

Time frame: week 0 - week 12

Secondary Outcomes

Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment

24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP

Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment

Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP

Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18

Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18

Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Data from ClinicalTrials.gov

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Tustin, California, United States

Unnamed facility

Aventura, Florida, United States

Unnamed facility

DeLand, Florida, United States

Unnamed facility

Hialeah, Florida, United States

Unnamed facility

Pembroke Pines, Florida, United States

Unnamed facility

Avon, Indiana, United States

Unnamed facility

Indianapolis, Indiana, United States

Unnamed facility

Las Vegas, Nevada, United States

...and 11 more locations

Time frame: week 0 - week 12

Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean daytime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean nighttime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, BP\<120/70, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75, DBP\<70 at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12

number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 3

Time frame: week 0 - week 3

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6

Time frame: week 0 - week 6

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9

Time frame: week 0 - week 9

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12

Time frame: week 0 - week 12

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15

Time frame: week 0 - week 15

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18

Time frame: week 0 - week 18

Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions

number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 3

Time frame: week 0 - week 3

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6

Time frame: week 0 - week 6

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9

Time frame: week 0 - week 9

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12

Time frame: week 0 - week 12

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15

Time frame: week 0 - week 15

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18

Time frame: week 0 - week 18